510(k) K953268 ยท LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT
| Applicant | Stelkast Company, Pittsburgh PA, US |
| Decision | Substantially Equivalent, Jan 17, 1996 |
| Received | Jul 13, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953268
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2009 | Stelkast Co Dual Taper Wedge Pressed Fit Femoral Component.
The Dual Taper Wedge is a single use device intended for pressed fit reconstruciton of the femoral portion of severely disable and/or very painful hip Terminated |
LWJ | None listed |
| Jan 28, 2009 | Stelkast Co Stelkast Dual Taper Wedge Pressed Fit Femoral Component. Hip Prosthesis, Part number SC1439 Terminated |
LWJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.